Imagery-based Coping for Cocaine Use Disorder

NCT ID: NCT03656653

Last Updated: 2019-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-30

Study Completion Date

2020-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A pragmatic, 4-week, 4-group, between-subjects, factorial randomised controlled trial conducted at a specialist NHS outpatient addictions clinic and hospital clinical research facility to determine if mental imagery (of past and future positive \[recovery oriented\] and negative \[cocaine aversive\] events) can help reduce cue-induced cocaine craving and cocaine use.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Cocaine, a powerful stimulant drug, is used by 2.2% of people aged 16-59 in England and each year about 150.000 people seek help for cocaine use disorder from the NHS or non-governmental organisations (NGO). There are currently no approved medication-assisted treatments or specific psychosocial interventions for CUD. General counselling is offered by the NHS and NGO addiction services, but this is not particularly effective.

The transition from regular cocaine use to cocaine abuse is often marked by intense episodes (binges), which may last several days and are followed by a 'crash' with no or little use. For many people, repeated administration of cocaine over a short duration of time creates vivid episodic memories of euphoria which can inform future craving content. Craving or strong urges are a distinctive feature of CUD and are often reported as involuntary, distressing and uncontrollable.

Research has demonstrated that craving experiences can be voluntarily evoked or elicited by conditioned drug cues in the environment and internal processes such mood or physical sensations. The associations between cues and use are established through classical and instrumental reward-based conditioning and are important for the development and maintenance of CUD. Enhanced attention to cocaine cues develops and remains heightened for at least six months into abstinence.

Craving-related experiences are informed by memories of intense reward, physical sensations and include pro-drug beliefs, appraisals, expectancies and vivid mental imagery. Drug-imagery is often initially pleasurable and affectively charged and can motivate drug-seeking behaviour. If impeded or delayed, drug imagery highlights a deficit and can be experienced as distressing and intrusive. Treatment of intrusive images has been successful in various psychological disorders using imagery rescripting. Imagery rescripting has recently been used in memory-focused cognitive therapy to help reduce cocaine craving. Reducing intrusive image-induced negative affect through positive imagery is important for relieving psychological distress but there is also evidence that aversive imagery may reduce maladaptive approach behaviours.

This will be a pragmatic, 4-week, 2x2, between-subjects, factorial randomised controlled trial. It will be conducted at a specialist NHS outpatient addictions clinic (Lorraine Hewitt House; LHH) operated by South London and Maudsley NHS Foundation trust (SLaM) and at the NIHR Wellcome Trust King's Clinical Research Facility (CRF) at King's College Hospital.

Informed consenting adult participants will be randomised to one of four conditions:

* future-based (prospective) recovery-oriented imagery;
* future-based (prospective) cocaine-aversive imagery;
* past (autobiographical) recovery-oriented imagery; or
* past (autobiographical) cocaine-aversive imagery.

Participants will undergo a craving induction procedure designed to elicit cue-induced craving. In response to elevated craving, participants will be asked to reduce their craving levels using a mental imagery intervention.

Following the procedure in the research facility, participants will be given a digital audio player to take home. This will contain a recording of the imagery condition they are allocated to. Participants will be asked to listen to this recording each day during a 14-day follow-up, and ad libertatem when experiencing cocaine craving. After 14 days participants will be invited for a follow up conducted at the community addictions clinic.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cocaine Use Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Future-based recovery-oriented imagery

Mental Imagery for Craving Reduction: mental imagery aimed at describing a future without cocaine use

Group Type EXPERIMENTAL

Mental Imagery for Craving Reduction

Intervention Type BEHAVIORAL

a behavioural mental imagery intervention where participants are asked to generate specific mental images to reduce cue-induced craving for cocaine use disorder

Future-based cocaine-aversive imagery

Mental Imagery for Craving Reduction: mental imagery aimed at describing a future where cocaine is causing significant distress

Group Type EXPERIMENTAL

Mental Imagery for Craving Reduction

Intervention Type BEHAVIORAL

a behavioural mental imagery intervention where participants are asked to generate specific mental images to reduce cue-induced craving for cocaine use disorder

Past recovery-oriented imagery

Mental Imagery for Craving Reduction: mental imagery aimed at describing a past event without cocaine use

Group Type EXPERIMENTAL

Mental Imagery for Craving Reduction

Intervention Type BEHAVIORAL

a behavioural mental imagery intervention where participants are asked to generate specific mental images to reduce cue-induced craving for cocaine use disorder

Past cocaine-aversive imagery

Mental Imagery for Craving Reduction: mental imagery aimed at describing a past event where cocaine use has caused significant distress

Group Type EXPERIMENTAL

Mental Imagery for Craving Reduction

Intervention Type BEHAVIORAL

a behavioural mental imagery intervention where participants are asked to generate specific mental images to reduce cue-induced craving for cocaine use disorder

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mental Imagery for Craving Reduction

a behavioural mental imagery intervention where participants are asked to generate specific mental images to reduce cue-induced craving for cocaine use disorder

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adult (18 years and over; no upper limit);
* English speaking (to a level sufficient to engage with a psychosocial intervention);
* Current diagnosis for primary CUD alone, with concurrent opiate use disorder or while enrolled in opioid agonist therapy \*
* Self-reported regular use of crack cocaine;
* Stated motivation to reduce or quit cocaine use;

Exclusion Criteria

* Current post-traumatic stress disorder (PTCI score \>100);
* Suicide attempt in the past 3 months;
* Participants with harmful alcohol consumption (\>50 units per week men; \>35 units women);
* Cocaine hydrochloride (powder form) users; \*\*
* Non-English Speaking;
* Clinically significant on-going medical problems that might make participation unsafe;
* Uncontrolled Mental Health Disorder;
* Severe neurocognitive impairment (Montreal Cognitive Assessment \<17);
* Current enrolment in an addiction treatment related clinical research study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

South London and Maudsley NHS Foundation Trust

OTHER

Sponsor Role collaborator

King's College London

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

John Marsden

Role: PRINCIPAL_INVESTIGATOR

King's College London

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Lorraine Hewitt House

London, , United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Camille Goetz

Role: CONTACT

Phone: 00447928331625

Email: [email protected]

John Marsden

Role: CONTACT

Phone: 004420 7848 0830

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Luke Mitcheson, DCLinPsy

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

18?LO/1013

Identifier Type: -

Identifier Source: org_study_id